CN101332316B - 生物型鼻梁植入体 - Google Patents
生物型鼻梁植入体 Download PDFInfo
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- CN101332316B CN101332316B CN200810029656.0A CN200810029656A CN101332316B CN 101332316 B CN101332316 B CN 101332316B CN 200810029656 A CN200810029656 A CN 200810029656A CN 101332316 B CN101332316 B CN 101332316B
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Abstract
本发明公开了一种生物型鼻梁植入体，它是以动物的肌腱或韧带为原料，按如下步骤制成：(1)对动物的肌腱或韧带进行预处理；(2)脱细胞处理；(3)加工成型；(4)环氧交联固定处理；(5)除抗原处理；(6)病毒灭活；(7)诱导活性修饰；(8)灭菌。本发明的生物型鼻梁植入体是纯天然材料制成，它的组成及结构与人体组织相似，生物相容性好，稳定性高，不轻易降解，只有在宿主组织长入时才作被动降解，植入不引起免疫排斥反应，可诱导组织再生，与宿主周围组织长合为一体，并逐渐变为宿主组织，有真实质感，无异物刺激，不会发生移位、蚀穿外露等并发症。动物实验及临床试验效果良好，是新一代天然鼻梁植入体。
Description
技术领域
本发明涉及医用植入器械领域，具体地说，涉及一种鼻梁植入体。
背景技术
隆鼻是美容整容最常见的手术，目前用于隆鼻的鼻梁植入体全是由硅橡胶或膨体聚四氟乙烯制成，这两种材料虽然具有生物惰性，植入后可与人体和平共处。但由于其组成和结构与人体无任何相似，无法与受主组织长合为一体，易发生移位、磨损，蚀穿外露，细心观察质感仍有差异等缺点。
发明内容
本发明的目的是提供一种生物相容性良好，无免疫排异反应，能与受主组织愈合为一体的生物型鼻梁植入体。
为了实现上述目的，本发明采用如下技术方案：
一种生物型鼻梁植入体，它是以动物的肌腱或韧带为原料，按如下步骤制成：
(1)对动物的肌腱或韧带进行预处理；
(2)脱细胞处理；
(3)加工成型；
(4)环氧交联固定处理；
(5)除抗原处理；
(6)病毒灭活；
(7)诱导活性修饰；
(8)灭菌。
在上述步骤中，步骤(1)所述预处理为采用广谱消毒剂浸泡消毒，去除杂质，并修剪成易于成型的坯料。
在上述步骤中，步骤(2)所述的脱细胞处理是用酶将细胞壁酶解或用表面活性剂破坏细胞壁并进行洗脱处理，以脱除其中的细胞，也可以两者兼用。酶解法是用胃蛋白酶或胰蛋白酶或两者的复合酶分解破坏其中的细胞。表面活性剂优选曲拉通X100、吐温-20或OP-10。
在上述步骤中，步骤(3)所述的加工成型是指通过模具及机械加工的方法将坯料加工成尾部为一个弧形薄翼，向头部逐渐收窄为柱体，头部为一曲尺状柱体，弯曲处为一半球形前突，与鼻突对应。
在上述步骤中，步骤(4)所述的环氧交联固定处理是将环氧化物与软骨以及基底骨中的胶原蛋白进行开环交联反应，使其中骨胶原保持稳定，不易变质和被微生物分解。所述环氧化物为
，R＝CnH2n+1或者是
，n为0～12中的整数。环氧化物浓度为0.1～1mol/L，反应温度在0℃～45℃之间选取，反应时间随所要求的稳定度而定，时间长稳定度高，不易降解，一般在2～96小时之间。
在上述步骤中，步骤(5)所述的除抗原处理是指用除抗原剂封闭引起免疫排异反应的特异基团和改变其引起免疫排异反应的特异构象。封闭特异基团所用的除抗原剂主要是一些易与-NH2，-OH，-SH等基团中的活泼氢起反应的亲核试剂，它们是酸酐、酰氯、酰胺、环氧化物等；改变特异构象的除抗原剂是胍类化合物(如盐酸胍)等强氢键形成剂。
在上述步骤中，步骤(6)的病毒灭活步骤是采用1mol/L氢氧化钠溶液浸泡制品至少60分钟，温度为33～37℃。该步骤主要是为灭活可能存在的朊病毒而设计的，它能使朊病毒失活。
在上述步骤中，步骤(7)所述的诱导活性修饰是将可粘附生长因子及细胞的活性物质引入制品中，使植入后能粘附、富集机体自我修复机制释放并输送到创伤区的生长因子及干细胞，在制品上长时间高效表达，诱导干细胞定向分化为修复组织的母细胞，再分裂增殖，再生出新的组织，最终自体化为自身的鼻梁组织。所用的活性物质是多肽或糖胺聚糖。多肽主要是含16个赖氨酸及精-甘-天冬氨酸的一类多肽，如赖(16)-甘-精-甘-天冬-丝-脯-半胱多肽；糖胺聚糖主要是透明质酸、硫酸软骨素、硫酸皮质素、硫酸角质素、肝素、硫酸乙酰肝素一类粘多糖物质。引入方式可以是偶联、化学吸附、物理吸附和胶原膜包裹等；优选偶联方式，偶联剂可用二酸内酐，二酰二胺，二酰二氯，双环氧化物，碳化二亚胺等双官能团物质。
在上述步骤中，步骤(8)所述的灭菌是用指用中国药典及美国药典规定的25KGy的Co60-γ射线辐照灭菌法。该法能杀灭除朊病毒外的已知病原体。
与现有技术相比，本发明具有如下有益效果：
与目前应用的硅橡胶及膨体聚四氟乙烯的鼻梁植入体相比，本发明的生物型鼻梁植入体的优点在于它是纯天然材料制成，以动物的肌腱/韧带为原料，经炼制和加工成型，再经环氧固定，多方位除抗原技术及组织诱导技术等系列生化技术处理制成。它的组成及结构与人体组织相似，生物相容性好，稳定性高，不轻易降解，只有在宿主组织长入时才作被动降解，植入不引起免疫排斥反应，可诱导组织再生，与宿主周围组织长合为一体，并逐渐变为宿主组织，有真实质感，无异物刺激，不会发生移位，蚀穿外露等并发症。动物实验及临床试验效果良好，是新一代天然鼻梁植入体。
附图说明
图1是生物型鼻梁植入体的结构示意图；
图2是生物型鼻梁植入体的样品照片；
具体实施方式
实施例1
取新鲜健康猪肌腱，放入0.1质量％新洁尔灭清毒液中浸泡60分钟，取出去除杂质，修剪成坯料，取出，洗净，放入胰蛋白酶的Tris盐酸缓冲液中，在室温下酶解10小时，取出，用水冲洗，放入含1μM苯甲基磺酸氟蛋白酶抑制剂的1％OP-10溶液中，浸泡8小时，取出，在搅拌下用水洗涤三次，取出，沥干水份，用专用模具加工成型为图1所示的形态并定型。放入固定反应器中用交联剂进行交联固定，交联剂为含环氧化物的溶液，环氧化物为
R＝(CH3)3C-CH2-，试剂浓度0.1mol/L，在室温下反应100小时。交联反应完成后，取出、洗净，放入除抗原反应装置中，加入乙酸酐，在室温下反应16小时，取出，洗涤，再用盐酸胍溶液反应一次，反应温度10℃，反应时间8小时，取出、洗净。放入诱导活性修饰专用反应器中，加入赖(16)-甘-精-甘-天冬-丝-脯-半胱多肽及己二酰二氯偶联剂，在25℃下，温和反应16小时，取出，充分洗净。用生理盐水保存液双层塑胶袋封装，送辐照灭菌，即得成品。
实施例2
取新鲜健康牛韧带，放入0.1质量％新洁尔灭清毒液中浸泡60分钟，取出去除杂质，修剪成坯料，取出，洗净，放入胰蛋白酶的Tris盐酸缓冲液中，在室温下酶解20小时，取出，用水冲洗，放入含1μM苯甲基磺酸氟蛋白酶抑制剂的1％OP-10溶液中，浸泡8小时，取出，在搅拌下用水洗涤三次，取出，沥干水份，用专用模具加工成型为图1所示形态并定型。放入固定反应器中用交联剂进行交联固定，交联剂为含环氧化物的溶液，环氧化物为
R＝(CH3)3C-CH2-，试剂浓度为0.5mol/L，在室温下反应50小时。交联反应完成后，取出、洗净，放入除抗原反应装置中，加入乙酰氯，在室温下反应10小时。取出，洗涤。再用盐酸胍溶液反应一次，反应温度10℃，反应时间8小时。取出、洗净，放入1mol/L氢氧化钠溶液中在30℃下浸泡处理60分钟，弃去反应液。用稀酸中和残余氢氧化钠，洗净。放入诱导活性修饰专用反应器中，加入赖(16)-甘-精-甘-天冬-丝-脯-半胱多肽及碳化二亚胺偶联剂，在23℃下，温和反应8小时，取出，充分洗净。用生理盐水保存液双层塑胶袋封装，送辐照灭菌，即得成品。
Claims (4)
1.一种生物型鼻梁植入体，其特征在于它是以动物的肌腱或韧带为原料，按如下步骤制成：
(1)对动物的肌腱或韧带进行预处理；
(2)脱细胞处理；
(3)加工成型；
(4)环氧交联固定处理；
(5)除抗原处理；
(6)病毒灭活；
(7)诱导活性修饰；
(8)灭菌；
步骤(2)所述的脱细胞处理是用酶将细胞壁酶解或用表面活性剂破坏细胞壁并进行洗脱处理；
步骤(4)所述的环氧交联固定处理是将环氧化物与组成材料的基本成份胶原蛋白进行开环交联反应，所述环氧化物为R＝CnH2n+1或者是
n为0～12中的整数；
步骤(5)所述的除抗原处理是采用除抗原剂进行处理，所述除抗原剂为羧酸酐、酰氯、酰胺、环氧化物或胍类化合物；
步骤(6)的病毒灭活步骤是采用1mol/L氢氧化钠溶液浸泡制品至少60分钟，温度为33～37℃；
步骤(7)所述的诱导活性修饰是将活性物质引入制品中；所述活性物质为多肽或糖胺聚糖；引入方式为采用偶联剂偶联、化学吸附、物理吸附或胶原膜包裹。
2.根据权利要求1所述的生物型鼻梁植入体，其特征在于所述多肽为赖(16)-甘-精-甘-天冬-丝-脯-半胱构成的多肽；所述糖胺聚糖为透明质酸、硫酸软骨素、硫酸皮质素、硫酸角质素、肝素或硫酸乙酰肝素；所述偶联剂为羧二酸内酐、二酰二胺、二酰二氯、双环氧化物、或碳化二亚胺。
3.根据权利要求1所述的生物型鼻梁植入体，其特征在于步骤(1)所述预处理为采用广谱消毒剂浸泡消毒，去除杂质和修剪。
4.根据权利要求1所述的生物型鼻梁植入体，其特征在于步骤(8)所述的灭菌是用25KGy的Co60-γ射线辐照灭菌。
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| US12/284,816 US20100023124A1 (en) | 2008-07-22 | 2008-09-25 | Biological nasal bridge implant and method of manufacturing |
| PCT/CN2009/000818 WO2010009616A1 (en) | 2008-07-22 | 2009-07-22 | Biological nasal bridge implant and method of manufacture |
| RU2011102170/15A RU2499612C2 (ru) | 2008-07-22 | 2009-07-22 | Биологический имплант переносицы и способ его изготовления |
| JP2011519006A JP2011528586A (ja) | 2008-07-22 | 2009-07-22 | 鼻筋用生体インプラント及びその製造方法 |
| EP09799932.0A EP2320966B1 (en) | 2008-07-22 | 2009-07-22 | Biological nasal bridge implant and method of manufacture |
| US13/361,563 US20120128785A1 (en) | 2006-07-28 | 2012-01-30 | Biological nasal bridge implant and method of manufacture |
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| CN101829359B (zh) * | 2010-04-16 | 2013-04-03 | 中国人民解放军第二军医大学 | 脱细胞韧带支架和种子细胞复合培养方法 |
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| CN104788692A (zh) * | 2015-04-30 | 2015-07-22 | 上海欣吉特生物科技有限公司 | 一种灭活胶原材料及其制备方法 |
| CN106510900A (zh) * | 2016-12-08 | 2017-03-22 | 大连裕辰科技发展有限公司 | 一种用于鼻部整形填充同种肋软骨的材料及其制备方法 |
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| CN101172165A (zh) * | 2007-11-16 | 2008-05-07 | 广东冠昊生物科技有限公司 | 生物型骨修复材料 |
| CN201182778Y (zh) * | 2007-11-16 | 2009-01-21 | 广州知光生物科技有限公司 | 生物型骨修复材料 |
| CN201271394Y (zh) * | 2008-07-22 | 2009-07-15 | 广州知光生物科技有限公司 | 生物型鼻梁植入体 |
-
2008
- 2008-07-22 CN CN200810029656.0A patent/CN101332316B/zh active Active
- 2008-09-25 US US12/284,816 patent/US20100023124A1/en not_active Abandoned
-
2009
- 2009-07-22 JP JP2011519006A patent/JP2011528586A/ja active Pending
- 2009-07-22 RU RU2011102170/15A patent/RU2499612C2/ru not_active IP Right Cessation
- 2009-07-22 EP EP09799932.0A patent/EP2320966B1/en active Active
- 2009-07-22 WO PCT/CN2009/000818 patent/WO2010009616A1/en active Application Filing
-
2012
- 2012-01-30 US US13/361,563 patent/US20120128785A1/en not_active Abandoned
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1394653A (zh) * | 2002-06-20 | 2003-02-05 | 武汉大学 | 一种隆鼻材料及其制备方法 |
| CN1903144A (zh) * | 2005-07-29 | 2007-01-31 | 广东冠昊生物科技有限公司 | 生物型人工韧带及其制备方法 |
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| 田晋洪 等.隆鼻术中各种充填材料的比较.《中国美容医学》.2006,第15卷(第5期),第605-607页. * |
Also Published As
| Publication number | Publication date |
|---|---|
| EP2320966A4 (en) | 2012-09-26 |
| CN101332316A (zh) | 2008-12-31 |
| US20100023124A1 (en) | 2010-01-28 |
| EP2320966B1 (en) | 2013-09-11 |
| RU2011102170A (ru) | 2012-07-27 |
| US20120128785A1 (en) | 2012-05-24 |
| RU2499612C2 (ru) | 2013-11-27 |
| WO2010009616A1 (en) | 2010-01-28 |
| EP2320966A1 (en) | 2011-05-18 |
| JP2011528586A (ja) | 2011-11-24 |
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